Julie Swedberg, CPA
I can still remember the “break-up.”
It was about a year ago during what was supposed to be a routine 6-week scan followed by my regular infusion according to the clinical trial protocol. Instead, it was a day full of tears and heartache.
I had developed seven brain metastases despite having a complete response in my body to amivantamab during a phase I clinical trial for NSCLC at Mayo Clinic. I would not be receiving my infusion that day. Instead, I met with my oncologist to discuss our plan going forward and potential next line of treatment. Fast forward to a whirlwind gamma knife procedure and movement to a new line of treatment (which I am still on as of this writing).
I still think about that day with sadness—not just from the standpoint that I no longer was able to participate in the trial, but also because I did not feel closure from the experience.
From the Editor
“Offboarding from clinical trials is a difficult, emotionally wrought process for which many, if not most, patients are unprepared. The prospect of tumor progression can engender fear and anxiety, which must be addressed adequately so patients can remain emotionally whole. Failure to do so can prove crippling. Unfortunately, many institutions do a suboptimal job of handling this challenging aspect of clinical research.”
—Corey Langer, MD
Editor, ILCN
The level of care that I received was top notch, and I truly felt connected to my care team. Until that day, I had been traveling to Mayo Clinic every 3 weeks. I would sit down with my oncologist and the clinical trial coordinator to go over my side effects, how I was feeling, both mentally and physically, and review my labs to make sure I was okay to receive that week’s infusion. Then I would move to the clinical trials unit where a team of nurses would spend the next 6 hours getting me ready for the infusion, monitoring me during the infusion, and making sure I was doing okay. Every 6 weeks I would have PET scans to track my progress on the trial. While I complained every time about the frequency of the PET scans, it was somewhat reassuring to be so much on top of what was happening with the cancer in my body.
When I left the trial, I felt a little lost for a few months. I was so used to seeing my care team on such a frequent schedule that when that was gone, I felt as if my cancer was not being monitored effectively. I switched to an every 3-month cycle versus every 3 weeks, and I went through a little bit of “care-withdrawal.”
I missed seeing my oncologist. I missed seeing my trial coordinator. I missed all the nurses in the clinical trial unit. I missed knowing what was going on every 6 weeks. My anxiety and worry increased as the level of care decreased. My logical mind knew I was still being monitored effectively, but my emotional mind got the best of me.
The onboarding and preparation to participate in a clinical trial is arduous and intense—meetings, paperwork, testing, coordination with the pharmaceutical company, reviewing potential side effects over the course of several weeks.
The offboarding, in my opinion, was the exact opposite. A “ghosting” of sorts.
While I still have quarterly check-ins with the trial coordinator, the abrupt and sudden halting of the intense level of care left me with medical “whiplash” and a good amount of anxiety for a few months. I signed paperwork that same day that acknowledged I was done with the trial. That was pretty much all that happened in terms of offboarding.
I believe a more formal offboarding procedure for clinical trial participants, supported by pharmaceutical companies, would ultimately improve the well-being of patients, and encourage them to continue to seek out further clinical trial opportunities. The patient is prepared to the nth degree for what happens before and during the trial but is left ill-prepared for what happens if they need to move on to another treatment and monitoring schedule.
This is an unmet need.
